ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
FDA 510(k) clearance K001588 · decided 2000-08-17
Clearance details
- K-number
- K001588
- Device name
- ARTHROCARE SYSTEM 2000 CONTROLLER, ARTHROCARE SYSTEM 2000 CABLE, ARTHROCARE SYSTEM 2000 FOOTSWITCH, ARTHROCARE SYSTEM 20
- Applicant
- Arthrocare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-05-23
- Decision date
- 2000-08-17
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- GXI
- Device class
- 2
- Regulation number
- 882.4725
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.